Systems and methods for anchoring and sealing a prosthetic heart valve

ABSTRACT

A method of implanting a prosthetic heart valve includes advancing a prosthetic heart valve to an implantation location within a patient&#39;s body, positioning the prosthetic heart valve within a native heart valve annulus, expanding a frame of the prosthetic heart valve from a first contracted configuration to a first expanded configuration, and then contracting the frame to a second contracted configuration. The prosthetic heart valve may be repositioned and then re-expanded from the second contracted configuration to a second expanded configuration. The prosthetic heart valve is preferably released from the delivery apparatus while in the second expanded configuration. Releasing the prosthetic heart valve from the delivery apparatus may result in radial expansion of a flange portion of the prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/191,054, filed Jun. 23, 2016, which claims the benefit of U.S.Provisional Application No. 62/183,562, filed Jun. 23, 2015. Eachrelated application is incorporated by reference herein.

FIELD OF THE DISCLOSURE

The present disclosure relates generally to prosthetic heart valves andmethods for replacing diseased or defective native heart valves, andmore particularly to an expandable prosthetic heart valve includingfeatures for anchoring and sealing the prosthetic heart valve onto anative human heart and related methods for implanting the prostheticheart valve to replace a diseased or defective native heart valve.

BACKGROUND OF THE DISCLOSURE

Various types of prosthetic heart valves are commonly used in valvereplacement surgery to replace a diseased or defective native heartvalve, such as an aortic valve, a mitral valve, a pulmonary valve, or atricuspid valve, of a native human heart. A prosthetic heart valvegenerally may include a frame or other support structure configured forpositioning at an implantation site at or near the native heart valveand anchoring onto the native heart, and an occluder member, such as amulti-leaflet valve, attached to the frame and configured forcontrolling blood flow through the prosthetic heart valve. Uponimplantation of the prosthetic heart valve, the frame may maintain therelative position of the prosthetic heart valve within the native heart,and the occluder member may control blood flow in a manner similar tothe native heart valve, thereby restoring desired function of the heart.

According to traditional procedures, heart valve replacement may beperformed via open heart surgery, which may require cardiopulmonarybypass and may present a significant risk of certain complications. Inrecent years, less-invasive procedures for heart valve replacement havebeen developed, which may eliminate the need for cardiopulmonary bypassand may decrease the risk of complications as compared to open heartsurgery. For example, certain prosthetic heart valves may be implantedvia a transapical approach, a transatrial approach, a transfemoralapproach, a transseptal approach, a subclavian approach, a direct aorticpuncture approach, or other vascular access approaches. Each type ofapproach for implanting prosthetic heart valves may present certainbenefits and drawbacks. For example, the transapical approach mayprovide a direct, “straight shot” approach for replacing certain nativeheart valves, may allow a physician to leverage past experience inperforming transcatheter aortic valve replacement (TAVR) procedures, andmay allow a physician to have high degree of control over the prostheticheart valve and instruments used to implant the heart valve. However,the transapical approach may be challenging in certain patients due topoor tissue quality at the apex of the heart and/or a relatively largeouter diameter of the prosthetic heart valve being implanted, may resultin left ventricle dysfunction, may present issues of sub-valvularentanglement, and may be more invasive than other potential approaches.

The transatrial approach may provide a direct antegrade approach forreplacing certain native heart valves, may avoid sub-valvular anatomy,may eliminate the need to puncture the left ventricle, and may be lesssensitive to the size of the outer diameter of the prosthetic heartvalve being implanted. However, the transatrial approach may presentchallenges in steering and navigating the prosthetic heart valve throughthe anatomy to the desired implantation site, may present a steeplearning curve for a physician having experience only with thetransapical approach, and may be more invasive than other potentialapproaches. The transseptal approach may provide a direct antegradeapproach for replacing certain native heart valves, may eliminate theneed to puncture the left ventricle, and may allow a physician toleverage past experience in performing other procedures through atransseptal puncture. However, the transseptal approach may presentchallenges in steering and navigating the prosthetic heart valve throughthe anatomy to the desired implantation site, may require a physician todeliver the prosthetic heart valve over a relatively long distance ascompared to other potential approaches, may present challenges inpatients having an atrial and/or septal defect, in particular when theprosthetic heart valve has a relatively large outer diameter, and mayrequire venous or arterial access in order to deliver the prostheticheart valve to the desired implantation site.

Currently, less-invasive approaches are most commonly used in performingaortic valve replacement procedures, although it would be desirable touse less-invasive approaches in replacing mitral valves, pulmonaryvalves, and/or tricuspid valves in a similar manner. In view of thedifferences between the aortic valve and the other native heart valves,however, prosthetic heart valves and related instruments configured foraortic valve replacement generally would not be suitable for replacingthe other native heart valves. Accordingly, there remains a need for aprosthetic heart valve that is suitable for replacement of the mitralvalve, the pulmonary valve, and/or the tricuspid valve. It will beappreciated that a prosthetic heart valve configured for mitral,pulmonary, and/or tricuspid valve replacement may require certaindifferences in design and function, as compared to prosthetic heartvalves configured for aortic valve replacement, in order to be implantedvia a less-invasive approach and to function in a suitable manner. Inparticular, such a prosthetic heart valve should accommodate or conformto the shape and structure of the native heart valve and/or surroundinganatomy without compromising the integrity or function of thesurrounding anatomy or the occluder member of the prosthetic heartvalve. Such a prosthetic heart valve also should securely anchor ontothe native heart tissue to prevent or inhibit migration of theprosthetic heart valve from the implantation site. Further, such aprosthetic heart valve should form a seal against the native hearttissue to prevent or inhibit paravalvular leakage.

SUMMARY OF THE DISCLOSURE

Various embodiments described herein provide prosthetic heart valves andrelated methods for implanting a prosthetic heart valve to replace adiseased or defective native heart valve. According to one aspect, aprosthetic heart valve for replacing a diseased or defective nativeheart valve is provided. In one embodiment, the prosthetic heart valvemay include an outer frame, an inner frame positioned at least partiallywithin the outer frame, and an occluder member positioned at leastpartially within the inner frame. The prosthetic heart valve also mayinclude an atrial flange extending from an atrial end of the outerframe, and a ventricular flange extending from a ventricular end of theouter frame, wherein at least a portion of the atrial flange extendsradially outward beyond the ventricular flange.

In another embodiment, the prosthetic heart valve may include an outerframe having a D-shaped cross-sectional shape in a plane orthogonal to alongitudinal axis of the prosthetic heart valve, and an inner framepositioned at least partially within the outer frame and having acircular cross-sectional shape in the plane orthogonal to thelongitudinal axis of the prosthetic heart valve. The prosthetic heartvalve also may include an occluder member positioned at least partiallywithin the inner frame, an atrial flange extending from an atrial end ofthe outer frame, and a ventricular flange extending from a ventricularend of the outer frame.

In still another embodiment, the prosthetic heart valve may include anexpandable outer frame having a D-shaped cross-sectional shape in aplane orthogonal to a longitudinal axis of the prosthetic heart valve,and an expandable inner frame positioned at least partially within theouter frame and having a circular cross-sectional shape in the planeorthogonal to the longitudinal axis of the prosthetic heart valve. Theprosthetic heart valve also may include an occluder member positioned atleast partially within the inner frame, an atrial flange extending froman atrial end of the outer frame, and a ventricular flange extendingfrom a ventricular end of the outer frame, wherein at least a portion ofthe atrial flange extends radially outward beyond the ventricularflange.

These and other aspects and embodiments of the present disclosure willbe apparent or will become apparent to one of ordinary skill in the artupon review of the following detailed description when taken inconjunction with the several drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

In describing the various embodiments of the present disclosure,reference is made to the accompanying drawings, which are notnecessarily drawn to scale, and wherein:

FIG. 1A is a side view of a prosthetic heart valve and a portion of adelivery device in accordance with one or more embodiments of thepresent disclosure, showing the prosthetic heart valve in an expandedstate.

FIG. 1B is a side view of an outer frame, an inner frame, an atrialflange/skirt, and a ventricular flange/skirt of the prosthetic heartvalve and a portion of the delivery device of FIG. 1A, showing theprosthetic heart valve in the expanded state.

FIG. 1C is a top perspective view of the prosthetic heart valve and aportion of the delivery device of FIG. 1A, showing the prosthetic heartvalve in the expanded state.

FIG. 1D is a top perspective view of the outer frame, the inner frame,the atrial flange/skirt, and the ventricular flange/skirt of theprosthetic heart valve and a portion of the delivery device of FIG. 1A,showing the prosthetic heart valve in the expanded state.

FIG. 1E is a bottom perspective view of the prosthetic heart valve and aportion of the delivery device of FIG. 1A, showing the prosthetic heartvalve in the expanded state.

FIG. 1F is a bottom perspective view of the outer frame, the innerframe, the atrial flange/skirt, and the ventricular flange/skirt of theprosthetic heart valve and a portion of the delivery device of FIG. 1A,showing the prosthetic heart valve in the expanded state.

FIG. 2A is a side view of a prosthetic heart valve in accordance withone or more embodiments of the present disclosure, showing theprosthetic heart valve in an expanded state.

FIG. 2B is a top view of the prosthetic heart valve of FIG. 2A, showingthe prosthetic heart valve in the expanded state.

FIG. 2C is a bottom view of the prosthetic heart valve of FIG. 2A,showing the prosthetic heart valve in the expanded state.

FIG. 2D is a side view of an outer frame, an atrial flange/skirt, and aventricular flange/skirt of the prosthetic heart valve of FIG. 2A,showing the outer frame, the atrial flange/skirt, and the ventricularflange/skirt in the expanded state.

FIG. 2E is a perspective view of a portion of the prosthetic heart valveof FIG. 2A and a portion of a delivery device attached to the prostheticheart valve, showing the prosthetic heart valve in the expanded stateand an anchor of the prosthetic heart valve in a deployed state.

FIG. 2F is a detailed side view of a portion of the prosthetic heartvalve of FIG. 2A, showing the anchor of the prosthetic heart valve inthe deployed state.

FIG. 2G is a bottom perspective view of the outer frame of theprosthetic heart valve of FIG. 2A and a portion of the delivery device,showing the outer frame in the expanded state.

FIG. 2H is a detailed side view of a portion of the prosthetic heartvalve of FIG. 2A and a portion of the delivery device, showing a petalof the atrial flange/skirt of the prosthetic heart valve in a collapsedstate.

FIG. 2I is a detailed side view of a portion of the prosthetic heartvalve of FIG. 2A, showing petals of the atrial flange/skirt in anexpanded state.

FIG. 2J is a partial cross-sectional side view of the prosthetic heartvalve of FIG. 2A positioned within a native mitral valve of a nativehuman heart, showing the outer frame and the atrial flange/skirt of theprosthetic heart valve in a collapsed state and the ventricularflange/skirt in an expanded state.

FIG. 3A is a side view of a sheathed prosthetic heart valve, beginning aseries in FIGS. 3A-3F showing a computer-assisted mitral valvereplacement of the invention.

FIG. 3B is a side view of the prosthetic heart valve of FIG. 3A showingunsheathing of the ventricular skirt.

FIG. 3C is a composite top view, a side view and a computer generatedpositioning top view of the prosthetic heart valve of FIG. 3A showingcontrolled expansion of the frame, allowing repositioning orre-sheathing by contracting the frame.

FIG. 3D is a top view of the prosthetic heart valve of FIG. 3A showingthe atrial petals open for positioning and hemodynamic functionverification.

FIG. 3E is a composite of a top perspective view and a top view of theprosthetic heart valve of FIG. 3A showing release of the control wiresin the final position.

FIG. 3F is a composite top view and a bottom view of the prostheticheart valve of FIG. 3A showing removing the guide wire and finalverification of the valve position and function.

FIG. 3G is a top view of a prosthetic heart valve, beginning a series inFIGS. 3G-3L, showing how a single articulating operation minimizescomplexity in re-sheathing atrial petals after deployment.

FIG. 3H is a bottom perspective view of the prosthetic heart valve ofFIG. 3G showing how control wires pass outside or within slots in atrialpetals to enable inward deflection.

FIG. 3I is a bottom perspective view of the prosthetic heart valve ofFIG. 3G showing coordinated contraction of stent and forward motion ofsheath to allow for petals to be retracted into the frame.

FIG. 3J is a side view of the prosthetic heart valve of FIG. 3G showingcontraction and re-sheathing.

FIG. 3K is a side view of the prosthetic heart valve of FIG. 3G showingthat the structure from a multi-lumen tube allows the use of wires topull petals inward without damaging the tip.

FIG. 3L is a side view of the prosthetic heart valve of FIG. 3G showingthe tip recoiling into a straight configuration after passing over theimplant.

DETAILED DESCRIPTION OF THE DISCLOSURE

Various embodiments of the present disclosure provide improvedexpandable prosthetic heart valves, delivery devices, and methods forreplacing diseased or defective native heart valves. Such expandableprosthetic heart valves, delivery devices, and methods may address oneor more of the above-described drawbacks of existing technology forheart valve replacement. As described below, the expandable prostheticheart valves, delivery devices, and methods provided herein may beconfigured for mitral valve replacement, although the expandableprosthetic heart valves, delivery devices and methods alternatively maybe configured for aortic, pulmonary, or tricuspid valve replacement.

Embodiments of the present disclosure are described herein below withreference to the accompanying drawings, in which some, but not all,embodiments are shown. Indeed, the prosthetic heart valves, deliverydevices, and methods disclosed may be embodied in many different formsand should not be construed as limited to the embodiments set forthherein; rather, these embodiments are provided so that this disclosureis thorough and complete and fully conveys the scope of the prostheticheart valves, delivery devices, and methods to those skilled in the art.Like reference numbers refer to like elements throughout. The singularforms “a,” “an,” and “the” can refer to plural instances unless thecontext clearly dictates otherwise or unless explicitly stated.

As described in detail below, the embodiments of the present disclosureprovide improved prosthetic heart valves, delivery devices, and methodsfor replacing diseased or defective native heart valves, such as mitralvalves, aortic valves, pulmonary valves, or tricuspid valves, of anative human heart. In particular, some embodiments of the prostheticheart valve may be configured for mitral valve replacement and may beimplanted via open heart surgery or less-invasive approaches, such as atransapical approach, a transatrial approach, a transfemoral approach, atransseptal approach, a subclavian approach, a direct aortic punctureapproach, or other vascular access approaches. Such embodiments of theprosthetic heart valve may accommodate the shape and structure of thenative mitral valve and the surrounding anatomy without compromising theintegrity or function of the surrounding anatomy. Such embodiments ofthe prosthetic heart valve also may securely anchor onto the nativeheart tissue to prevent or inhibit migration of the prosthetic heartvalve from the implantation site. Further, such embodiments of theprosthetic heart valve may form a seal against the native heart tissueto prevent or inhibit paravalvular leakage.

Although the following description focuses primarily on use of theprosthetic heart valve for mitral valve replacement, it will beunderstood that some embodiments of the prosthetic heart valve may beconfigured for use in aortic, pulmonary, or tricuspid valve replacement.As will be appreciated by one of ordinary skill in the art, developmentof a prosthetic heart valve for replacement of the native mitral valvemay present numerous technical and clinical challenges which must betaken in to account in order to provide a suitable prosthetic heartvalve for mitral, aortic, pulmonary, or tricuspid valve replacement. Forexample, technical challenges and considerations include, but are notlimited to, implanting the prosthetic heart valve at a narrow landingsite on the native heart with limited imaging of the native heartanatomy and the prosthetic heart valve during implantation, navigatingand accommodating the three-dimensional, dynamic native heart anatomyand complex sub-valvular features, accommodating the pressure gradientat the desired implantation site and the annular loads applied to theprosthetic heart valve by the native heart anatomy, providing adequatesealing against the native heart anatomy to prevent or inhibitparavalvular leakage, gaining access to the desired implantation siteand guiding a relatively large prosthetic heart valve through thevasculature to the implantation site, avoiding undesirable thrombosisthat may inhibit desired function of the prosthetic heart valve and/orsurrounding features of the native heart, avoiding left ventricularoutflow tract obstruction (LVOTO), and avoiding systolic anterior motion(SAM) of the mitral valve chordae tendinae. Clinical challenges andconsiderations include, but are not limited to, accommodating theparticular complications of the sick population in need of valvereplacement, identifying and addressing multiple and very differentetiologies, such as ischemic, dilated cardiomyopathy, degenerative, andrheumatic etiologies, addressing an increased international normalizedratio (INR) because of thrombus potential including gastro-intestinaland other bleeds, and addressing atrial fibrillation.

According to one aspect, a prosthetic heart valve for replacing adiseased or defective native heart valve is provided. In one embodiment,the prosthetic heart valve may include an outer frame, an inner framepositioned at least partially within the outer frame, and an occludermember positioned at least partially within the inner frame. Theprosthetic heart valve also may include an atrial flange extending froman atrial end of the outer frame, and a ventricular flange extendingfrom a ventricular end of the outer frame, wherein at least a portion ofthe atrial flange extends radially outward beyond the ventricularflange.

In another embodiment, the prosthetic heart valve may include an outerframe having a D-shaped cross-sectional shape in a plane orthogonal to alongitudinal axis of the prosthetic heart valve, and an inner framepositioned at least partially within the outer frame and having acircular cross-sectional shape in the plane orthogonal to thelongitudinal axis of the prosthetic heart valve. The prosthetic heartvalve also may include an occluder member positioned at least partiallywithin the inner frame, an atrial flange extending from an atrial end ofthe outer frame, and a ventricular flange extending form a ventricularend of the outer frame.

In still another embodiment, the prosthetic heart valve may include anexpandable outer frame having a D-shaped cross-sectional shape in aplane orthogonal to a longitudinal axis of the prosthetic heart valve,and an expandable inner frame positioned at least partially within theouter frame and having a circular cross-sectional shape in the planeorthogonal to the longitudinal axis of the prosthetic heart valve. Theprosthetic heart valve also may include an occluder member positioned atleast partially within the inner frame, an atrial flange extending froman atrial end of the outer frame, and a ventricular flange extendingfrom a ventricular end of the outer frame, wherein at least a portion ofthe atrial flange extends radially outward beyond the ventricularflange.

Various aspects of the prosthetic heart valves, delivery devices, andmethods described herein build upon those described in the followingpatent applications, which are incorporated by reference herein, intheir entirety, for all purposes: U.S. application Ser. No. 11/888,009,filed Jul. 31, 2007; U.S. application Ser. No. 12/822,291, filed Jun.24, 2010; U.S. application Ser. No. 13/339,236, filed Dec. 28, 2011;U.S. application Ser. No. 13/656,717, filed Oct. 21, 2012; U.S.application Ser. No. 13/772,203, filed Feb. 20, 2013; U.S. applicationSer. No. 14/208,997, filed Mar. 13, 2014; U.S. application Ser. No.14/278,594, filed May 15, 2014; PCT Application No. PCT/US2007/017061,filed Jul. 31, 2007; PCT Application No. PCT/US2011/067695, filed Dec.29, 2011; PCT Application No. PCT/US2012/061292, filed Oct. 22, 2012;PCT Application No. PCT/US2013/027072, filed Feb. 21, 2013; and PCTApplication No. PCT/US2014/038305, filed May 16, 2014. As will beappreciated by one of ordinary skill in the art, various features of theprosthetic heart valves, delivery devices, and methods described hereinmay be incorporated into the prosthetic heart valves, delivery devices,and methods described in the foregoing applications, and variousfeatures of the prosthetic heart valves, delivery devices, and methodsdescribed in the foregoing applications may be incorporated into theprosthetic heart valves, delivery devices, and methods described herein.

Referring now to the drawings, FIGS. 1A-1F illustrate an expandableprosthetic heart valve 100 (which also may be referred to as a “heartvalve” or a “heart valve device”) according to one or more embodimentsof the disclosure. In some embodiments, the prosthetic heart valve 100may be configured for implantation at a diseased or defective nativemitral valve of a human heart to replace the function of the nativemitral valve. In other embodiments, the prosthetic heart valve 100 maybe configured for implantation at a diseased or defective native aorticvalve, pulmonary valve, or tricuspid valve of a human heart to replacethe function of the native valve. As described below, the prostheticheart valve 100 may accommodate the shape and structure of the nativemitral valve and the surrounding anatomy without compromising theintegrity or function of the surrounding anatomy, may securely anchoronto the native heart tissue to prevent or inhibit migration of theprosthetic heart valve 100 from the implantation site, and may form aseal against the native heart tissue to prevent or inhibit paravalvularleakage. Ultimately, the prosthetic heart valve 100 may restore desiredfunction of the native heart by controlling blood flow in a mannersimilar to the native mitral valve being replaced.

The prosthetic heart valve 100 may be formed as a generally tubularstructure having an elongated shape extending along a longitudinal axisof the heart valve 100. The prosthetic heart valve 100 may be implantedwithin the native mitral valve such that the longitudinal axis of theprosthetic heart valve 100 is generally aligned with the longitudinalaxis of the native mitral valve. When positioned at the desiredimplantation site, an end portion of the heart valve 100 may bepositioned within the left atrium of the heart, another end portion ofthe heart valve 100 may be positioned within the left ventricle of theheart, and an intermediate portion of the heart valve 100 may bepositioned within the annulus of the native mitral valve. In thismanner, the prosthetic heart valve 100 may have an atrial end 102 (whichalso may be referred to as a “proximal end” or a “first end”) and anventricular end 104 (which also may be referred to as a “distal end” ora “second end”) positioned opposite the atrial end 102 along thelongitudinal axis of the heart valve 100. As described below, theprosthetic heart valve 100 may be expandable, such that the heart valve100 may be moved between a collapsed state for delivery of the heartvalve 100 to the desired implantation site and an expanded state foranchoring the heart valve 100 to the heart at the implantation site. Inparticular, the prosthetic heart valve 100 maybe configured forcontrolled expansion into one of a number of expanded states, such thatthe heart valve 100 may be expanded to an expanded state thatcorresponds to the size and shape of the anatomy of a particularpatient. The prosthetic heart valve 100 also may be configured forcontrolled contraction from an expanded state toward or to the collapsedstate, such that the heart valve 100 may be at least partially collapsedin order to reposition the heart valve 100 with respect to the heartanatomy, if necessary. In this manner, the prosthetic heart valve 100may provide significant advantages over existing heart valves that areeither self-expanding or are expanded by a balloon or other mechanismand do not provide a means for easily contracting or repositioning theheart valve.

The prosthetic heart valve 100 may include an outer frame 110 (whichalso may be referred to as a “radially outer frame”) and an inner frame120 (which also may be referred to as a “radially inner frame”)positioned at least partially within the outer frame 110. The outerframe 110 may be a generally tubular structure having an elongated shapeextending along the longitudinal axis of the heart valve 100. The outerframe 110 may be formed as a lattice or stent-like structure thatradially expands and collapses as the prosthetic heart valve 100 ismoved between the collapsed state and the expanded state. As shown, thelattice of the outer frame 110 may include a number of interconnectedwire members 112 configured to deflect and/or articulate as theprosthetic heart valve 100 is moved between the collapsed state and theexpanded state. The lattice of the outer frame 110 may be formed of ametal wire, although other materials and configurations of the latticemay be used. In some embodiments, the outer frame 110 may be formed of ashape memory alloy, such as nitinol, or a shape memory polymer, althoughother suitable metals, alloys, and polymers may be used. The lattice ofthe outer frame 110 may be configured such that controlled changes inthe axial dimensions of the wire members 112 results in controlledchanges to the orthogonal dimensions or diameter of the outer frame 110.Changes to the dimensions of the lattice of the outer frame 110 may beprescribed by mechanical interaction between the wire members 112 andother mechanical elements, such as screws or rods, which may definedifferent positions for specific points in the lattice and, in doing so,may define an axial length of the lattice and thus its resultingdiameter. For example, the outer frame 110 may include a number ofactuator members 114 configured to facilitate movement of the prostheticheart valve 100 between the collapsed state and the expanded state. Insome embodiments, as shown, the actuator members 114 may include athreaded rod received within a threaded tube. The actuator members 114may be attached to a number of the wire members 112, thereby forming ascrew-jack mechanism to facilitate movement of the prosthetic heartvalve 100 between the collapsed state and the expanded state. In otherembodiments, the actuator members 114 may have other configurations forseparately articulating the wire members 112 and selectively moving allor a portion of the prosthetic heart valve 100 between the collapsedstate and the expanded state. In some embodiments, the actuator elementsare rods that have multiple points that generate mechanical interferencewith a selective locking element at different states of expansion orcontraction. The outer frame 110 may have a longitudinal axis which maybe coaxial with or spaced apart from the longitudinal axis of theprosthetic heart valve 100. The outer frame 110 may have an atrial end116 (which also may be referred to as a “proximal end” or a “firstend”), and a ventricular end 118 (which also may be referred to as a“distal end” or a “second end”) positioned opposite the atrial end 116along the longitudinal axis of the outer frame 110.

The inner frame 120 may be a generally tubular structure having anelongated shape extending along the longitudinal axis of the heart valve100. The inner frame 120 also may be formed as a lattice or stent-likestructure that radially expands and collapses as the prosthetic heartvalve 100 is moved between the collapsed state and the expanded state.As shown, the lattice of the inner frame 120 may include a number ofinterconnected wire members 122 configured to deflect and/or articulateas the prosthetic heart valve 100 is moved between the collapsed stateand the expanded state. The lattice of the inner frame 120 may be formedof a deformable metal wire, although other materials and configurationsof the lattice may be used. In some embodiments, the inner frame 120 maybe formed of a shape memory alloy, such as nitinol, or a shape memorypolymer, although other suitable metals, alloys, and polymers may beused. although other suitable The inner frame 120 may have alongitudinal axis which may be coaxial with or spaced apart from thelongitudinal axis of the prosthetic heart valve 100 and which may becoaxial with or spaced apart from the longitudinal axis of the outerframe 110. The inner frame 120 may have an atrial end 126 (which alsomay be referred to as a “proximal end” or a “first end”), and aventricular end 128 (which also may be referred to as a “distal end” ora “second end”) positioned opposite the atrial end 126 along thelongitudinal axis of the inner frame 120. As shown, the atrial end 126of the inner frame 120 may be positioned within the lumen of the outerframe 110, and the ventricular end 128 of the inner frame 120 may bepositioned outside of the lumen of the outer frame 110. In someembodiments, as shown, the ventricular end 128 of the inner frame 120may be positioned at the ventricular end 104 of the prosthetic heartvalve 100.

The outer frame 110 and the inner frame 120 may have a variety ofcross-sectional shapes in a plane orthogonal to the longitudinal axesthereof. In various embodiments, the outer frame 110 may have a circularshape, an elliptical shape, a “D”-shape, a square shape, a rectangularshape, a polygonal shape, a curved shape, or a shape having one or morecurved sections and one or more straight sections in the planeorthogonal to the longitudinal axis of the outer frame 110. In someembodiments, the cross-sectional shape of the outer frame 110 may beconstant along the longitudinal direction. In other embodiments, thecross-sectional shape of the outer frame 110 may vary along thelongitudinal direction. In some embodiments, the size of thecross-sectional shape of the outer frame 110 may be constant along thelongitudinal direction. In other embodiments, the size of thecross-sectional shape of the outer frame 110 may vary along thelongitudinal direction. In various embodiments, the inner frame 120 mayhave a circular shape, an elliptical shape, a “D”-shape, a square shape,a rectangular shape, a polygonal shape, a curved shape, or a shapehaving one or more curved sections and one or more straight sections inthe plane orthogonal to the longitudinal axis of the inner frame 120. Insome embodiments, the cross-sectional shape of the inner frame 120 maybe constant along the longitudinal direction. In other embodiments, thecross-sectional shape of the inner frame 120 may vary along thelongitudinal direction. In some embodiments, the size of thecross-sectional shape of the inner frame 120 may be constant along thelongitudinal direction. In other embodiments, the size of thecross-sectional shape of the inner frame 120 may vary along thelongitudinal direction. In some embodiments, the outer frame 110 mayhave a “D”-shape and the inner frame 120 may have a circular shape. Inthis manner, the outer frame 110 may be shaped to accommodate thegenerally “D”-shape of the native mitral valve, while the inner frame120 may be shaped to accommodate an occluder member, such as amulti-leaflet valve, having a generally circular shape. Notably, use ofthe “D”-shaped outer frame 110 may reduce the possibility of leftventricular outflow tract obstruction. In other embodiments, the outerframe 110 may have a circular shape and the inner frame 120 may have acircular shape. In still other embodiments, the outer frame 110 and theinner frame 120 may have other shapes, which may be the same as ordifferent from one another. In some embodiments, the outer frame 110 andthe inner frame 120 may have the same longitudinal heights, althoughdifferent longitudinal heights of the outer frame 110 and the innerframe 120 may be used in other embodiments.

As shown, the outer frame 110 and the inner frame 120 may be connectedto one another by a trampoline 130 (which also may be referred to as an“intermediate frame” or an “intermediate support”) that extends radiallybetween the outer frame 110 and the inner frame 120. In this manner, thetrampoline 130 may maintain a relative position of the inner frame 120with respect to the outer frame 110 and may guide the inner frame 120during expansion and contraction of the prosthetic heart valve 100. Inparticular, the trampoline 130 may transfer forces from the outer frame110 to the inner frame 120 as the outer frame 110 is expanded orcollapsed, thereby causing the inner frame 120 to expand or collapse ina similar manner. As shown, the trampoline 130 may be formed as alattice including a number of interconnected wire members 132 configuredto deflect and/or articulate as the prosthetic heart valve 100 is movedbetween the collapsed state and the expanded state. The trampoline 130may provide a contoured transition between the outer frame 110 and theinner frame 120, particularly when the outer frame 110 and the innerframe 120 have different cross-sectional shapes. In some embodiments,the trampoline 130 may be attached to the outer frame 110 and the innerframe 120 by mechanical fasteners, welding, soldering, bonding, chemicalbonding or attachment, or other suitable means of attachment. In otherembodiments, the outer frame 110, the inner frame 120, and thetrampoline 130 may be formed from a single piece of material, which maybe bent to form the respective shapes of the outer frame 110, the innerframe 120, and the trampoline 130.

As shown, the prosthetic heart valve 100 also may include a pair offlanges attached to the outer frame 110. In particular, the prostheticheart valve 100 may include an atrial flange 140 (which also may bereferred to as an “atrial skirt,” a “proximal flange,” a “proximalskirt,” or an “extended sealing surface”) attached to the atrial end 116of the outer frame 110 and extending axially and/or radially outwardtherefrom. In some embodiments, the atrial flange 140 may be spacedapart from and positioned along the outer surface of the outer frame 110distally from the atrial end 116 of the outer frame 110. Duringimplantation of the prosthetic heart valve 100, the atrial flange 140may be positioned within the left atrium of the heart and in appositionagainst a tissue surface therein above the mitral valve annulus. Theatrial flange 140 may be flexible such that the atrial flange 140 may becollapsed and expanded along with the outer frame 110 to facilitatepositioning and anchoring of the outer frame 110 at the implantationsite. As shown, the atrial flange 140 may include a number of petals 142positioned in a circumferential array along the circumference of theouter frame 110. The petals 142 may be formed of a metal or polymerwire, although other materials and configurations of the petals 142 maybe used. In some embodiments, the petals 142 may be formed of wire meshor stent lattice.

The prosthetic heart valve 100 also may include a ventricular flange 150(which also may be referred to as a “ventricular skirt,” a “distalflange,” a “distal skirt,” or an “extended sealing surface”) attached tothe ventricular end 118 of the outer frame 110 and extending axially andradially outward therefrom. In some embodiments, the ventricular flange150 may be spaced apart from and positioned along the outer surface ofthe outer frame 110 proximally from the ventricular end 118 of the outerframe 110. During implantation of the prosthetic heart valve 100, theventricular flange 150 may be positioned within the left ventricle ofthe heart and in apposition against a tissue surface therein below themitral valve annulus. The ventricular flange 150 may be flexible suchthat the ventricular flange 150 may be collapsed and expanded along withthe outer frame 110 to facilitate positioning and anchoring of the outerframe 110 at the implantation site. As shown, the ventricular flange 150may include a number of petals 152 positioned in a circumferential arrayalong the circumference of the outer frame 110. The petals 152 may beformed of a metal or polymer wire, although other materials andconfigurations of the petals 152 may be used. In some embodiments, thepetals 152 may be formed of wire mesh or stent lattice.

Notably, the atrial flange 140 and the ventricular flange 150 mayfacilitate mechanical interference based anchoring of the prostheticheart valve 100 onto the heart as well as pressure-driven sealingbetween the heart valve 100 and the mating heart tissue. Such anchoringand sealing benefits may be particularly advantageous in mitral valvereplacement because the presence of the left ventricular outflow tract,the more compliant tissue, the shorter annuli, and the increased area ofdilated annuli do not allow for reliance only on radial force forsealing and anchoring, as in aortic valve replacement. In someembodiments, the ventricular flange 150 may be larger than the atrialflange 140, such that the ventricular flange 150 has a largercross-sectional area than the atrial flange 140 in the plane orthogonalto the longitudinal axis of the. In some embodiments, at least a portionof the ventricular flange 150 may extend radially outward beyond theatrial flange 140. In other embodiments, the ventricular flange 150 mayextend radially outward beyond the atrial flange 140 along the entirecircumference of the flanges 140, 150. In some embodiments, all of thepetals 142 of the atrial flange 140 may have the same size, with thesame axial length and the same radial length. In other embodiments, thepetals 142 of the atrial flange 140 may vary in their axial lengthand/or their radial length along the circumference of the atrial flange140. In some embodiments, one or more of the petals 142 configured to bepositioned at or near the trigones of the mitral valve may be stifferand/or longer that a remainder of the petals 142. In this manner, suchembodiments may provide enhanced anchoring about the trigones of themitral valve. In some embodiments, all of the petals 152 of theventricular flange 150 may have the same size, with the same axiallength and the same radial length. In other embodiments, the petals 152of the ventricular flange 150 may vary in their axial length and/ortheir radial length along the circumference of the ventricular flange150. In some embodiments, one or more of the petals 152 configured to bepositioned at or near the trigones of the mitral valve may be stifferand/or longer that a remainder of the petals 152. In this manner, suchembodiments may provide enhanced anchoring about the trigones of themitral valve.

As shown, the prosthetic heart valve 100 may include a biocompatiblecovering 160 (which also may be referred to as a “membrane”) positionedover portions of the outer frame 110, the inner frame 120, thetrampoline 130, the atrial flange 140, and/or the ventricular flange150. The outer frame 110, the inner frame 120, the trampoline 130, theatrial flange 140, and/or the ventricular flange 150 each may bepartially or entirely covered by the covering 160, according to variousembodiments. The covering 160 may be formed as a single componentpositioned over the respective portions of the heart valve 100 or asmultiple components positioned over the respective portions of the heartvalve 100. In some embodiments, the covering 160 extends over the outersurfaces and/or the inner surfaces of the outer frame 110, the innerframe 120, the trampoline 130, the atrial flange 140, and/or theventricular flange 150. In some embodiments, the covering 160 is formedof a biocompatible cloth or textile material, although other suitablematerials may be used for the covering 160. When the prosthetic heartvalve 100 is implanted, the covering 160 may promote hemostasis at theimplantation site, preventing or inhibiting blood flow around the heartvalve 100. The covering 160 also may promote tissue ingrowth orovergrowth to facilitate anchoring of the prosthetic heart valve 100 tothe heart tissue.

The prosthetic heart valve 100 further may include an occluder member170 (which also may be referred to simply as an “occluder”) attached tothe inner frame 120 and positioned at least partially within the lumenthereof. The occluder member 170 may be configured to control blood blowthrough the prosthetic heart valve 100 in a manner similar to the nativeheart valve being replaced. In some embodiments, as shown, the occludermember 170 may be a multi-leaflet valve including a number of leaflets172 arranged to form a one-way valve to control blood flow therebetween.The leaflets 172 may be formed of a metal, a polymer, a ceramic, acomposite material, or a bioprosthetic material. For example, theleaflets 172 may be bioprosthetic leaflets of treated animal tissue,such as porcine, bovine, or equine tissue. In other embodiments, theoccluder member 170 may include one or more spheres, one or more discs,one or more rotating plates, or other types of members configured tocontrol blood flow. Any such embodiments may be configured as aone-directional occluder member, allowing blood flow therethrough in onedirection and preventing blood flow in an opposite direction.

In some embodiments, the prosthetic heart valve 100 also may include oneor more anchors attached to the outer frame 110 and extending radiallyoutward therefrom. During implantation of the prosthetic heart valve100, the anchors may be configured to pierce or create a mechanicalinterference with the surrounding heart tissue, such as the nativemitral valve annulus. In this manner, the anchors may further secure theposition of the prosthetic heart valve 100 at the implantation site. Insome embodiments, the anchors may be fixed relative to the outer frame110 and may engage the surrounding heart tissue as the prosthetic heartvalve 100 is expanded within the native mitral valve. In otherembodiments, the anchors may be deployed from a retracted state forpositioning of the prosthetic heart valve 100 to a deployed state forengaging the surrounding heart tissue. In some embodiments, the anchorsmay be formed as prongs or hooks, although other configurations of theanchors may be used.

The prosthetic heart valve 100 may be delivered to the desiredimplantation site and anchored to the native heart via a delivery device180. As shown, the delivery device 180 may include a shaft 182 with aguide tip 184 attached to a distal end of the shaft 182. During use ofthe delivery device 180, the guide tip 184 and a distal portion of theshaft 182 may extend through the prosthetic heart valve 100, as shown,to guide the prosthetic heart valve 100 through the vasculature to theimplantation site. The delivery device 180 also may include a sheathpositioned over the shaft 182 and configured to retain the prostheticheart valve 100 in the collapsed state therein until the distal endportion of the delivery device 180 reaches the implantation site. Thesheath then may be retracted to expose the prosthetic heart valve 100.The delivery device 180 also may include a number of control wires 186configured to attach to the actuator members 114 of the outer frame 110.In some embodiments, the control wires 186 may be threaded andconfigured to threadably attach to the actuator members 114, althoughother means of attachment may be used. After the prosthetic heart valve100 is exposed and positioned within the native mitral valve, thecontrol wires 186 may be manipulated to actuate the actuator members114, thereby causing the outer frame 110 to controllably expand from thecollapsed state. As described above, expansion of the outer frame 110also may cause the inner frame 120 to expand. The prosthetic heart valve100 may be expanded in this manner within the native mitral valve untilthe outer surface of the outer frame 110 sufficiently engages the nativemitral valve annulus to maintain a relative position of the prostheticheart valve 100 with respect to the native mitral valve. Upon suchexpansion, the anchors, if present, may engage the mitral valve annulusor other heart tissue. Meanwhile, the ventricular flange 150 may expandwithin the left ventricle of the heart and engage the tissue surfacebelow the mitral valve annulus. Once the desired positioning of theprosthetic heart valve 100 within the native mitral valve is obtained,the control wires 186 may be disengaged from the actuator members 114.Upon disengaging the control wires 186, the atrial flange 140 may expandwithin the left atrium and engage the tissue surface above the mitralvalve annulus. Ultimately, the engagement between the outer frame 110and the mitral valve annulus, the engagement between the ventricularflange 150 and the mating tissue surface, and the engagement between theatrial flange 140 and the mating tissue surface may securely anchor theprosthetic heart valve 100 within the native mitral valve. Inembodiments that include the anchors, the engagement between the anchorsand the mating tissue may further anchor the prosthetic heart valve 100.Meanwhile, the engagement between the covering 160 and the mating tissuesurfaces, the engagement between the ventricular flange 150 and themating tissue surface, and the engagement between the atrial flange 140and the mating tissue surface may provide one or more seals that preventor inhibit blood flow around the prosthetic heart valve 100 and also maypromote tissue ingrowth or overgrowth to further seal and anchor theprosthetic heart valve 100. The prosthetic heart valve 100 describedherein may be configured for anchoring onto a mitral valve annulushaving a commissural diameter in the range of between 2 cm and 7 cm,which may cover a majority of patients in need of heart valvereplacement.

FIGS. 2A-2J illustrate an expandable prosthetic heart valve 200 (whichalso may be referred to as a “heart valve” or a “heart valve device”)according to one or more embodiments of the disclosure. In someembodiments, the prosthetic heart valve 200 may be configured forimplantation at a diseased or defective native mitral valve of a humanheart to replace the function of the native mitral valve. In otherembodiments, the prosthetic heart valve 200 may be configured forimplantation at a diseased or defective native aortic valve, pulmonaryvalve, or tricuspid valve of a human heart to replace the function ofthe native valve. As described below, the prosthetic heart valve 200 mayaccommodate the shape and structure of the native mitral valve and thesurrounding anatomy without compromising the integrity or function ofthe surrounding anatomy, may securely anchor onto the native hearttissue to prevent or inhibit migration of the prosthetic heart valve 200from the implantation site, and may form a seal against the native hearttissue to prevent or inhibit paravalvular leakage. Ultimately, theprosthetic heart valve 200 may restore desired function of the nativeheart by controlling blood flow in a manner similar to the native mitralvalve being replaced.

The prosthetic heart valve 200 may be formed as a generally tubularstructure having an elongated shape extending along a longitudinal axisof the heart valve 200. The prosthetic heart valve 200 may be implantedwithin the native mitral valve such that the longitudinal axis of theprosthetic heart valve 200 is generally aligned with the longitudinalaxis of the native mitral valve. When positioned at the desiredimplantation site, an end portion of the heart valve 200 may bepositioned within the left atrium of the heart, another end portion ofthe heart valve 200 may be positioned within the left ventricle of theheart, and an intermediate portion of the heart valve 200 may bepositioned within the annulus of the native mitral valve. In thismanner, the prosthetic heart valve 200 may have an atrial end 202 (whichalso may be referred to as a “proximal end” or a “first end”) and anventricular end 204 (which also may be referred to as a “distal end” ora “second end”) positioned opposite the atrial end 202 along thelongitudinal axis of the heart valve 200. As described below, theprosthetic heart valve 200 may be expandable, such that the heart valve200 may be moved between a collapsed state for delivery of the heartvalve 200 to the desired implantation site and an expanded state foranchoring the heart valve 200 to the heart at the implantation site. Inparticular, the prosthetic heart valve 200 may be configured forcontrolled expansion into one of a number of expanded states, such thatthe heart valve 200 may be expanded to an expanded state thatcorresponds to the size and shape of the anatomy of a particularpatient. The prosthetic heart valve 200 also may be configured forcontrolled contraction from an expanded state toward or to the collapsedstate, such that the heart valve 200 may be at least partially collapsedin order to reposition the heart valve 200 with respect to the heartanatomy, if necessary. In this manner, the prosthetic heart valve 200may provide significant advantages over existing heart valves that areeither self-expanding or are expanded by a balloon or other mechanismand do not provide a means for easily contracting or repositioning theheart valve.

The prosthetic heart valve 200 may include an outer frame 210 (whichalso may be referred to as a “radially outer frame”) and an inner frame220 (which also may be referred to as a “radially inner frame”)positioned at least partially within the outer frame 210. The outerframe 210 may be a generally tubular structure having an elongated shapeextending along the longitudinal axis of the heart valve 200. The outerframe 210 may be formed as a lattice or stent-like structure thatradially expands and collapses as the prosthetic heart valve 200 ismoved between the collapsed state and the expanded state. As shown, thelattice of the outer frame 210 may include a number of interconnectedwire members 212 configured to deflect and/or articulate as theprosthetic heart valve 200 is moved between the collapsed state and theexpanded state. The lattice of the outer frame 210 may be formed of ametal wire, although other materials and configurations of the latticemay be used. In some embodiments, the outer frame 210 may be formed of ashape memory alloy, such as nitinol, or a shape memory polymer, althoughother suitable metals, alloys, and polymers may be used. The lattice ofthe outer frame 210 may be configured such that controlled changes inthe axial dimensions of the wire members 212 results in controlledchanges to the orthogonal dimensions or diameter of the outer frame 210.Changes to the dimensions of the lattice of the outer frame 210 may beprescribed by mechanical interaction between the wire members 212 andother mechanical elements, such as screws or rods, which may definedifferent positions for specific points in the lattice and, in doing so,may define an axial length of the lattice and thus its resultingdiameter. For example, the outer frame 210 may include a number ofactuator members 214 configured to facilitate movement of the prostheticheart valve 200 between the collapsed state and the expanded state. Insome embodiments, as shown, the actuator members 214 may include athreaded rod received within a threaded tube. The actuator members 214may be attached to a number of the wire members 212, thereby forming ascrew-jack mechanism to facilitate movement of the prosthetic heartvalve 200 between the collapsed state and the expanded state. In otherembodiments, the actuator members 214 may have other configurations forarticulating the wire members 212 and moving the prosthetic heart valve200 between the collapsed state and the expanded state. The outer frame210 may have a longitudinal axis which may be coaxial with or spacedapart from the longitudinal axis of the prosthetic heart valve 200. Theouter frame 210 may have an atrial end 216 (which also may be referredto as a “proximal end” or a “first end”), and a ventricular end 218(which also may be referred to as a “distal end” or a “second end”)positioned opposite the atrial end 216 along the longitudinal axis ofthe outer frame 210.

The inner frame 220 may be a generally tubular structure having anelongated shape extending along the longitudinal axis of the heart valve200. The inner frame 220 also may be formed as a lattice or stent-likestructure that radially expands and collapses as the prosthetic heartvalve 200 is moved between the collapsed state and the expanded state.As shown, the lattice of the inner frame 220 may include a number ofinterconnected wire members 222 configured to deflect and/or articulateas the prosthetic heart valve 200 is moved between the collapsed stateand the expanded state. The lattice of the inner frame 220 may be formedof a deformable metal wire, although other materials and configurationsof the lattice may be used. In some embodiments, the inner frame 220 maybe formed of a shape memory alloy, such as nitinol, or a shape memorypolymer, although other suitable metals, alloys, and polymers may beused. although other suitable The inner frame 220 may have alongitudinal axis which may be coaxial with or spaced apart from thelongitudinal axis of the prosthetic heart valve 200 and which may becoaxial with or spaced apart from the longitudinal axis of the outerframe 210. The inner frame 220 may have an atrial end 226 (which alsomay be referred to as a “proximal end” or a “first end”), and aventricular end 228 (which also may be referred to as a “distal end” ora “second end”) positioned opposite the atrial end 226 along thelongitudinal axis of the inner frame 220. As shown, the atrial end 226of the inner frame 220 may be positioned within the lumen of the outerframe 210, and the ventricular end 228 of the inner frame 220 may bepositioned outside of the lumen of the outer frame 210. In someembodiments, as shown, the ventricular end 228 of the inner frame 220may be positioned at the ventricular end 204 of the prosthetic heartvalve 200.

The outer frame 210 and the inner frame 220 may have a variety ofcross-sectional shapes in a plane orthogonal to the longitudinal axesthereof. In various embodiments, the outer frame 210 may have a circularshape, an elliptical shape, a “D”-shape, a square shape, a rectangularshape, a polygonal shape, a curved shape, or a shape having one or morecurved sections and one or more straight sections in the planeorthogonal to the longitudinal axis of the outer frame 210. In someembodiments, the cross-sectional shape of the outer frame 210 may beconstant along the longitudinal direction. In other embodiments, thecross-sectional shape of the outer frame 210 may vary along thelongitudinal direction. In some embodiments, the size of thecross-sectional shape of the outer frame 210 may be constant along thelongitudinal direction. In other embodiments, the size of thecross-sectional shape of the outer frame 210 may vary along thelongitudinal direction. In various embodiments, the inner frame 220 mayhave a circular shape, an elliptical shape, a “D”-shape, a square shape,a rectangular shape, a polygonal shape, a curved shape, or a shapehaving one or more curved sections and one or more straight sections inthe plane orthogonal to the longitudinal axis of the inner frame 220. Insome embodiments, the cross-sectional shape of the inner frame 220 maybe constant along the longitudinal direction. In other embodiments, thecross-sectional shape of the inner frame 220 may vary along thelongitudinal direction. In some embodiments, the size of thecross-sectional shape of the inner frame 220 may be constant along thelongitudinal direction. In other embodiments, the size of thecross-sectional shape of the inner frame 220 may vary along thelongitudinal direction. In some embodiments, the outer frame 210 mayhave a “D”-shape and the inner frame 220 may have a circular shape. Inthis manner, the outer frame 210 may be shaped to accommodate thegenerally “D”-shape of the native mitral valve, while the inner frame220 may be shaped to accommodate an occluder member, such as amulti-leaflet valve, having a generally circular shape. Notably, use ofthe “D”-shaped outer frame 210 may reduce the possibility of leftventricular outflow tract obstruction. In other embodiments, the outerframe 210 may have a circular shape and the inner frame 220 may have acircular shape. In still other embodiments, the outer frame 210 and theinner frame 220 may have other shapes, which may be the same as ordifferent from one another. In some embodiments, the outer frame 210 andthe inner frame 220 may have the same longitudinal heights, althoughdifferent longitudinal heights of the outer frame 210 and the innerframe 220 may be used in other embodiments.

As shown, the outer frame 210 and the inner frame 220 may be connectedto one another by a trampoline 230 (which also may be referred to as an“intermediate frame” or an “intermediate support”) that extends radiallybetween the outer frame 210 and the inner frame 220. In this manner, thetrampoline 230 may maintain a relative position of the inner frame 220with respect to the outer frame 210 and may guide the inner frame 220during expansion and contraction of the prosthetic heart valve 200. Inparticular, the trampoline 230 may transfer forces from the outer frame210 to the inner frame 220 as the outer frame 210 is expanded orcollapsed, thereby causing the inner frame 220 to expand or collapse ina similar manner. As shown, the trampoline 230 may be formed as alattice including a number of interconnected wire members 232 configuredto deflect and/or articulate as the prosthetic heart valve 200 is movedbetween the collapsed state and the expanded state. The trampoline 230may provide a contoured transition between the outer frame 210 and theinner frame 220, particularly when the outer frame 210 and the innerframe 220 have different cross-sectional shapes. In some embodiments,the trampoline 230 may be attached to the outer frame 210 and the innerframe 220 by mechanical fasteners, welding, soldering, bonding, chemicalbonding or attachment, or other suitable means of attachment. In otherembodiments, the outer frame 210, the inner frame 220, and thetrampoline 230 may be formed from a single piece of material, which maybe bent to form the respective shapes of the outer frame 210, the innerframe 220, and the trampoline 230.

As shown, the prosthetic heart valve 200 also may include a pair offlanges attached to the outer frame 210. In particular, the prostheticheart valve 200 may include an atrial flange 240 (which also may bereferred to as an “atrial skirt,” a “proximal flange,” a “proximalskirt,” or an “extended sealing surface”) attached to the atrial end 216of the outer frame 210 and extending axially and/or radially outwardtherefrom. In some embodiments, the atrial flange 240 may be spacedapart from and positioned along the outer surface of the outer frame 210distally from the atrial end 216 of the outer frame 210. Duringimplantation of the prosthetic heart valve 200, the atrial flange 240may be positioned within the left atrium of the heart and in appositionagainst a tissue surface therein above the mitral valve annulus. Theatrial flange 240 may be flexible such that the atrial flange 240 may becollapsed and expanded along with the outer frame 210 to facilitatepositioning and anchoring of the outer frame 210 at the implantationsite. As shown, the atrial flange 240 may include a number of petals 242positioned in a circumferential array along the circumference of theouter frame 210. The petals 242 may be formed of a metal or polymerwire, although other materials and configurations of the petals 242 maybe used. In some embodiments, the petals 242 may be formed of wire meshor stent lattice.

The prosthetic heart valve 200 also may include a ventricular flange 250(which also may be referred to as a “ventricular skirt,” a “distalflange,” a “distal skirt,” or an “extended sealing surface”) attached tothe ventricular end 218 of the outer frame 210 and extending axially andradially outward therefrom. In some embodiments, the ventricular flange250 may be spaced apart from and positioned along the outer surface ofthe outer frame 210 proximally from the ventricular end 218 of the outerframe 210. During implantation of the prosthetic heart valve 200, theventricular flange 250 may be positioned within the left ventricle ofthe heart and in apposition against a tissue surface therein below themitral valve annulus. The ventricular flange 250 may be flexible suchthat the ventricular flange 250 may be collapsed and expanded along withthe outer frame 210 to facilitate positioning and anchoring of the outerframe 210 at the implantation site. As shown, the ventricular flange 250may include a number of petals 252 positioned in a circumferential arrayalong the circumference of the outer frame 210. The petals 252 may beformed of a metal or polymer wire, although other materials andconfigurations of the petals 252 may be used. In some embodiments, thepetals 252 may be formed of wire mesh or stent lattice.

Notably, the atrial flange 240 and the ventricular flange 250 mayfacilitate mechanical interference based anchoring of the prostheticheart valve 200 onto the heart as well as pressure-driven sealingbetween the heart valve 200 and the mating heart tissue. Such anchoringand sealing benefits may be particularly advantageous in mitral valvereplacement because the presence of the left ventricular outflow tract,the more compliant tissue, the shorter annuli, and the increased area ofdilated annuli do not allow for reliance only on radial force forsealing and anchoring, as in aortic valve replacement. In someembodiments, the ventricular flange 250 may be larger than the atrialflange 240, such that the ventricular flange 250 has a largercross-sectional area than the atrial flange 240 in the plane orthogonalto the longitudinal axis of the. In some embodiments, at least a portionof the ventricular flange 250 may extend radially outward beyond theatrial flange 240. In other embodiments, the ventricular flange 250 mayextend radially outward beyond the atrial flange 240 along the entirecircumference of the flanges 240, 250. In some embodiments, all of thepetals 242 of the atrial flange 240 may have the same size, with thesame axial length and the same radial length. In other embodiments, thepetals 242 of the atrial flange 240 may vary in their axial lengthand/or their radial length along the circumference of the atrial flange240. In some embodiments, one or more of the petals 242 configured to bepositioned at or near the trigones of the mitral valve may be stifferand/or longer that a remainder of the petals 242. In this manner, suchembodiments may provide enhanced anchoring about the trigones of themitral valve. In some embodiments, the petals on the anterior section ofthe valve which lie between the trigones may be shorter or have anotherpreferential shapes, so as to interfere less with the aortic root. Insome embodiments, all of the petals 252 of the ventricular flange 250may have the same size, with the same axial length and the same radiallength. In other embodiments, the petals 252 of the ventricular flange250 may vary in their axial length and/or their radial length along thecircumference of the ventricular flange 250. In some embodiments, one ormore of the petals 252 configured to be positioned at or near thetrigones of the mitral valve may be stiffer and/or longer that aremainder of the petals 252. In this manner, such embodiments mayprovide enhanced anchoring about the trigones of the mitral valve. Insome embodiments, the petals or any other anchor in the commissuralareas in the atrial and/or ventricular sides of the valve, may beconfigured by location or shape to pass partially or fully between theleaflets, at the commissural edge in order to interfere minimally withleaflet motion.

As shown, the prosthetic heart valve 200 may include a biocompatiblecovering 260 (which also may be referred to as a “membrane”) positionedover portions of the outer frame 210, the inner frame 220, thetrampoline 230, the atrial flange 240, and/or the ventricular flange250. The outer frame 210, the inner frame 220, the trampoline 230, theatrial flange 240, and/or the ventricular flange 250 each may bepartially or entirely covered by the covering 260, according to variousembodiments. The covering 260 may be formed as a single componentpositioned over the respective portions of the heart valve 200 or asmultiple components positioned over the respective portions of the heartvalve 200. In some embodiments, the covering 260 extends over the outersurfaces and/or the inner surfaces of the outer frame 210, the innerframe 220, the trampoline 230, the atrial flange 240, and/or theventricular flange 250. In some embodiments, the covering 260 is formedof a biocompatible cloth or textile material, although other suitablematerials may be used for the covering 260. When the prosthetic heartvalve 200 is implanted, the covering 260 may promote hemostasis at theimplantation site, preventing or inhibiting blood flow around the heartvalve 200. The covering 260 also may promote tissue ingrowth orovergrowth to facilitate anchoring of the prosthetic heart valve 200 tothe heart tissue.

The prosthetic heart valve 200 further may include an occluder member270 (which also may be referred to simply as an “occluder”) attached tothe inner frame 220 and positioned at least partially within the lumenthereof. The occluder member 270 may be configured to control blood blowthrough the prosthetic heart valve 200 in a manner similar to the nativeheart valve being replaced. In some embodiments, as shown, the occludermember 270 may be a multi-leaflet valve including a number of leaflets272 arranged to form a one-way valve to control blood flow therebetween.The leaflets 272 may be formed of a metal, a polymer, a ceramic, acomposite material, or a bioprosthetic material. For example, theleaflets 272 may be bioprosthetic leaflets of treated animal tissue,such as porcine, bovine, or equine tissue. In other embodiments, theoccluder member 270 may include one or more spheres, one or more discs,one or more rotating plates, or other types of members configured tocontrol blood flow. Any such embodiments may be configured as aone-directional occluder member, allowing blood flow therethrough in onedirection and preventing blood flow in an opposite direction.

In some embodiments, the prosthetic heart valve 200 also may include oneor more anchors 274 attached to the outer frame 210 and extendingradially outward therefrom. During implantation of the prosthetic heartvalve 200, the anchors 274 may be configured to pierce or create amechanical interference with the surrounding heart tissue, such as thenative mitral valve annulus. In this manner, the anchors 274 may furthersecure the position of the prosthetic heart valve 200 at theimplantation site. In some embodiments, the anchors 274 may be fixedrelative to the outer frame 210 and may engage the surrounding hearttissue as the prosthetic heart valve 200 is expanded within the nativemitral valve. In other embodiments, as shown, the anchors 274 may bedeployed from a retracted state for positioning of the prosthetic heartvalve 200 to a deployed state for engaging the surrounding heart tissue.In some embodiments, the anchors 274 may be formed as prongs or hooks,although other configurations of the anchors may be used.

The prosthetic heart valve 200 may be delivered to the desiredimplantation site and anchored to the native heart via a delivery device280. As shown, the delivery device 280 may include a shaft 282 with aguide tip 284 attached to a distal end of the shaft 282. During use ofthe delivery device 280, the guide tip 284 and a distal portion of theshaft 282 may extend through the prosthetic heart valve 200, as shown,to guide the prosthetic heart valve 200 through the vasculature to theimplantation site. The delivery device 280 also may include a sheathpositioned over the shaft 282 and configured to retain the prostheticheart valve 200 in the collapsed state therein until the distal endportion of the delivery device 280 reaches the implantation site. Thesheath then may be retracted to expose the prosthetic heart valve 200.The delivery device 280 also may include a number of control wires 286configured to attach to the actuator members 214 of the outer frame 210.In some embodiments, the control wires 286 may be threaded andconfigured to threadably attach to the actuator members 214, althoughother means of attachment may be used. After the prosthetic heart valve200 is exposed and positioned within the native mitral valve, thecontrol wires 286 may be manipulated to actuate the actuator members214, thereby causing the outer frame 210 to controllably expand from thecollapsed state. As described above, expansion of the outer frame 210also may cause the inner frame 220 to expand. The prosthetic heart valve200 may be expanded in this manner within the native mitral valve untilthe outer surface of the outer frame 210 sufficiently engages the nativemitral valve annulus to maintain a relative position of the prostheticheart valve 200 with respect to the native mitral valve. Upon suchexpansion, the anchors 274, if present, may engage the mitral valveannulus or other heart tissue. Meanwhile, the ventricular flange 250 mayexpand within the left ventricle of the heart and engage the tissuesurface below the mitral valve annulus. Once the desired positioning ofthe prosthetic heart valve 200 within the native mitral valve isobtained, the control wires 286 may be disengaged from the actuatormembers 214. Upon disengaging the control wires 286, the atrial flange240 may expand within the left atrium and engage the tissue surfaceabove the mitral valve annulus. Ultimately, the engagement between theouter frame 210 and the mitral valve annulus, the engagement between theventricular flange 250 and the mating tissue surface, and the engagementbetween the atrial flange 240 and the mating tissue surface may securelyanchor the prosthetic heart valve 200 within the native mitral valve. Inembodiments that include the anchors 274, the engagement between theanchors 274 and the mating tissue may further anchor the prostheticheart valve 200. Meanwhile, the engagement between the covering 260 andthe mating tissue surfaces, the engagement between the ventricularflange 250 and the mating tissue surface, and the engagement between theatrial flange 240 and the mating tissue surface may provide one or moreseals that prevent or inhibit blood flow around the prosthetic heartvalve 200 and also may promote tissue ingrowth or overgrowth to furtherseal and anchor the prosthetic heart valve 200. The prosthetic heartvalve 200 described herein may be configured for anchoring onto a mitralvalve annulus having a commissural diameter in the range of between 2 cmand 7 cm, which may cover a majority of patients in need of heart valvereplacement.

FIGS. 3A-3F show an exemplary method for controllably delivering anexpandable mitral valve with a double frame of an embodiment of thepresent invention. FIG. 3A shows the approach to the mitral valve. FIG.3B shows unsheathing of the ventricular skirt. FIG. 3C shows controlledexpansion of the frame, allowing repositioning or re-sheathing bycontracting the frame. FIG. 3D shows the atrial petals open forpositioning and hemodynamic function verification. Repositioning can beachieved by contracting the frame. Re-sheathing can be achieved bycontracting the frame and bringing in the petals with control wires.FIG. 3E shows two views of releasing the control wires in the finalposition. FIG. 3F shows two views of removing the guide wire and finalverification of the valve position and function.

In some embodiments, the steps described in FIGS. 3A-3F may be used todeploy the valve, in the proposed sequence or in another sequence ofsteps. The delivery may be transatrial, trans-apical, venous,trans-septal or any other vascular or non-vascular route. In oneembodiment the system may be electromechanical and computer controlledin order to facilitate the steps for delivery, deployment, anchoring,re-sheathing and release.

FIGS. 3G-3L show a method for controlled re-sheathing of an expandablemitral valve with petals of an embodiment of the present invention. FIG.3G illustrates how a single button operation minimizes complexity inre-sheathing atrial petals after deployment. FIG. 3H shows how controlwires pass outside or within slots in atrial petals to enable inwarddeflection. FIG. 3I shows coordinated contraction of stent and forwardmotion of sheath allow for petals to be retracted into the frame. FIG.3J shows that at minimum driven size, the sheath moves forward and canpass over a funneled ventricular skirt. FIG. 3K shows a super-elasticnitinol tip that forms a funnel to reduce friction, and that thestructure from a multi-lumen tube allows the use of wires to pull petalsinward without damaging the tip. FIG. 3L shows the nitinol tip recoilsinto a straight configuration after passing over the implant.

Therefore, in some embodiments, the valve maybe fully repositioned orre-sheathed as shown in the method illustrated in FIGS. 3G-3L. In orderto re-sheath the heart valve device, in some embodiments the controlwires of the delivery device maybe used to deflect the petals or otheranchoring members in order to re-sheath them. In one embodiment, thecontrol wires will pass on the outside of the ventricular or atrialpetals, so that so they can be used to deform inward those petals, orother anchoring elements, so that the sheath can move over them. In oneembodiment, guide elements or channels on the petals or control wiresmay be used so as to allow mechanical deflection without the wiresslipping on the surface of the petals. In some embodiments, those petalsmay be covered by a cloth or other surface coating which may interferewith forward sheath motion when moving forward over the petals or otheranchoring elements. In such cases, the control with other elongatedelements from the delivery device may be used to bend in preferentialdirections the cloth or other surface in order to minimize interferencewith the motion of the sheath. In other embodiments, other types ofmechanical elements, including but not limited to wires, rods and hooks,may extend from the delivery device and allow for inward deflection ofthe atrial and/or ventricular petals and/or other anchoring elements inorder to minimize interference with sheath in the re-sheathing process.

In some embodiments, the guide tip can have a shape or slit on itssurface to interfere with the tip of the sheath. In some embodiments,the tip of the sheath has a trumpet or expanded shape, which can becollapsed and sustained in the collapsed state by mechanicalinterference with the guide tip. As the sheath is retracted duringdeployment and interference is lost with the guide tip, the distal endof the sheath expands, which allows for easier re-sheathing of theimplant. An expandable sheath tip will also allow reduction of there-sheathing force and decrease interference when the sheath moves overthe petals or anchoring elements of the implant.

In some embodiments, the actuator elements can be independentlycontrolled in order to generate desired shape changes in the innerand/or outer frame. In some embodiments, actuators on the anteriorsection of the external frame can be controlled independently ofactuators in the posterior section of the outer frame. In thisembodiment, during expansion the user may preferentially expand theanterior section of the frame to achieve the correct inter-trigonallength and expand the posterior section of the frame in order to have animproved fit and seal of the elements against the tissue.

Many modifications of the embodiments of the present disclosure willcome to mind to one skilled in the art to which the disclosure pertainsupon having the benefit of the teachings presented herein through theforegoing descriptions and the associated drawings. Therefore, it is tobe understood that the present invention is not to be limited to thespecific embodiments disclosed and that modifications and otherembodiments are intended to be included within the scope of the appendedclaims. Although specific terms are employed herein, they are used in ageneric and descriptive sense only and not for purposes of limitation.

What is claimed is:
 1. A method of implanting a prosthetic heart valve,comprising: advancing a prosthetic heart valve to an implantationlocation within a patient's body, wherein the prosthetic heart valve isin a first radially contracted configuration and is releasably coupledto a delivery apparatus; positioning the prosthetic heart valve within anative heart valve annulus; expanding a frame of the prosthetic heartvalve from the first radially contracted configuration to a firstradially expanded configuration by actuating the delivery apparatus;contracting the frame of the prosthetic heart valve from the firstradially expanded configuration to a second radially contractedconfiguration by actuating the delivery apparatus; repositioning theprosthetic heart valve within the native heart valve annulus while theframe of the prosthetic heart valve is in the second radially contractedconfiguration; expanding the frame of the prosthetic heart valve fromthe second radially contracted configuration to a second radiallyexpanded configuration by actuating the delivery apparatus; andreleasing the prosthetic heart valve from the delivery apparatus whilethe prosthetic heart valve is in the second radially expandedconfiguration, wherein releasing the prosthetic heart valve from thedelivery apparatus results in radial expansion of a flange portion ofthe prosthetic heart valve.
 2. The method of claim 1, whereincontracting the frame occurs while the prosthetic heart valve isdisposed outside of a sheath of the delivery apparatus.
 3. The method ofclaim 2, wherein actuating the delivery apparatus includes moving one ormore actuation wires of the delivery apparatus relative to the frame ofthe prosthetic heart valve.
 4. The method of claim 3, wherein the frameof the prosthetic heart valve includes one or more actuation memberscoupled to the frame, and wherein each of the actuation wires of thedelivery apparatus is coupled to a respective actuation member of theprosthetic heart valve.
 5. The method of claim 1, wherein the prostheticheart valve comprises a plurality of actuator members coupled to theframe, wherein the delivery apparatus comprises a plurality of actuationwires releasably coupled to the actuator members of the prosthetic heartvalve, and wherein actuating the actuation wires of the deliveryapparatus while the delivery apparatus is coupled to the prostheticheart valve actuates the actuator members of the prosthetic heart valveand results in expansion or contraction of the frame of the prostheticheart valve.
 6. The method of claim 5, wherein the actuator members andthe actuation wires are rotatable relative to the frame of theprosthetic heart valve.
 7. The method of claim 6, wherein rotating theactuator members and the actuation wires in a first direction relativeto the frame of the prosthetic heart valve results in expansion of theprosthetic heart valve.
 8. The method of claim 6, wherein rotating theactuator members and the actuation wires in a second direction relativeto the frame of the prosthetic heart valve results in contraction of theprosthetic heart valve.
 9. The method of claim 5, wherein the actuationwires of the delivery apparatus are disposed radially outwardly from theflange portion of the prosthetic heart valve while the prosthetic heartvalve is coupled to the delivery apparatus.
 10. The method of claim 5,wherein the actuation wires of the delivery apparatus are disposedradially within slots formed in the flange portion of the prostheticheart valve while the prosthetic heart valve is coupled to the deliveryapparatus.
 11. A method of implanting a prosthetic heart valve,comprising: advancing a prosthetic heart valve through a patient'svasculature with a delivery apparatus such that the prosthetic heartvalve is disposed in or adjacent a native heart valve; deploying theprosthetic heart valve from a sheath of the delivery apparatus;expanding a frame of the prosthetic heart valve from a radiallycontracted configuration to a radially expanded configuration, whereinthe prosthetic heart valve comprising one or more flanges that areretained in an at least partially radially contracted configuration;contracting the frame of the prosthetic heart valve from the radiallyexpanded configuration to an at least partially radially contractedconfiguration; moving the prosthetic heart valve relative to the nativeheart valve annulus while the frame of the prosthetic heart valve is inthe at least partially radially contracted configuration; re-expandingthe frame of the prosthetic heart valve from the at least partiallyradially contracted configuration to the radially expandedconfiguration; releasing the prosthetic heart valve from the deliveryapparatus; and after releasing the prosthetic heart valve from thedelivery apparatus, expanding the one or more flanges of the prostheticheart valve from the at least partially radially contractedconfiguration to a radially expanded configuration.
 12. The method ofclaim 11, wherein contracting the frame occurs while the prostheticheart valve is radially outside and axially spaced from the sheath ofthe delivery apparatus.
 13. The method of claim 11, wherein the one ormore flanges of the prosthetic heart valve include a plurality of atrialpetals configured to engage native tissue on an atrial side of a nativemitral valve.
 14. The method of claim 13, wherein the delivery apparatusincludes one or more control wires that are disposed radially outwardlyfrom the atrial petals while the prosthetic heart valve is coupled tothe prosthetic heart valve, and wherein the one or more control wiresare configured to radially compress the atrial petals.
 15. The method ofclaim 11, wherein the one or more flanges of the prosthetic heart valveinclude a ventricular flange configured to engage native tissue on aventricular side of a native mitral valve.
 16. The method of claim 15,wherein the delivery apparatus includes one or more control wires thatare disposed radially outwardly from the ventricular flange while theprosthetic heart valve is coupled to the prosthetic heart valve, andwherein the one or more control wires are configured to radiallycompress the ventricular flange.
 17. The method of claim 11, wherein theprosthetic heart valve comprises a plurality of actuator members coupledto the frame, wherein the delivery apparatus comprises a plurality ofcontrol wires releasably coupled to the actuator members of theprosthetic heart valve, and wherein actuating the control wires of thedelivery apparatus while the delivery apparatus is coupled to theprosthetic heart valve moves the actuator members relative to the frameand expands or contracts the frame of the prosthetic heart valve. 18.The method of claim 17, wherein the control wires and the actuatormembers are rotatable relative to the frame of the prosthetic heartvalve, wherein rotating the control wires and the actuator members in afirst direction relative to the frame of the prosthetic heart valveresults in expansion of the frame of the prosthetic heart valve, andwherein rotating the control wires and the actuator members in a seconddirection relative to the frame of the prosthetic heart valve contractsthe frame of the prosthetic heart valve.
 19. A method of implanting aprosthetic heart valve, comprising: advancing a prosthetic heart valvethrough a patient's vasculature with a delivery apparatus such that theprosthetic heart valve is disposed in or adjacent a native heart valve;deploying the prosthetic heart valve from a sheath of the deliveryapparatus; after deploying the prosthetic heart valve, expanding a frameof the prosthetic heart valve from a radially contracted configurationto a radially expanded configuration by actuating one or more actuatorscoupled to the frame; contracting the frame of the prosthetic heartvalve from the radially expanded configuration to an at least partiallyradially contracted configuration by actuating the one or moreactuators; repositioning the prosthetic heart valve within the nativeheart valve annulus while the frame of the prosthetic heart valve is inthe at least partially radially contracted configuration; re-expandingthe frame of the prosthetic heart valve from the at least partiallyradially contracted configuration to the radially expanded configurationby actuating the one or more actuators; releasing the prosthetic heartvalve from the delivery apparatus; and after releasing the prostheticheart valve from the delivery apparatus, expanding one or more flangesof the prosthetic heart valve from an at least partially radiallycontracted configuration to a radially expanded configuration.
 20. Themethod of claim 19, wherein the frame of the prosthetic heart valve is afirst frame, wherein the prosthetic heart valve further comprises asecond frame coupled to and disposed radially outwardly from the firstframe, and wherein the one or more flanges are coupled to and extendradially outwardly from the second frame.